1. Field of the Invention
The present invention relates to a system and method for a web-based assessment and analysis of the risks of adverse effects resulting from the use of a particular drug, either alone or in combination with other drugs, nutrients, supplements, and other substances.
2. Description of the Related Art
In September 1997, information regarding cardiopulmonary disease related to the use of fenfluramine and phentermine (xe2x80x9cfen-phenxe2x80x9d) prompted the United States Food and Drug Administration (FDA) to request the manufacturers of these drugs to voluntarily withdraw both treatments for obesity from the market. Subsequent studies show a 25 percent incidence of heart valve disease apparently resulting from diet drug use. Thus, up to 1,250,000 people may have sustained heart valve damage from these diet drugs and the FDA indicates that this may be the largest adverse drug effect the agency has ever dealt with.
Current estimates are that some 2.2 million hospital patients had serious adverse drug reactions and more than 100,000 people die each year from adverse reactions to prescription drugs. Accordingly, federal officials have recommended that the FDA require hospitals to report all serious drug reactions to the agency. The Inspector General of the Department of Health and Human Services has also indicated that the FDA should also work to identify harmful effects of new drugs and encourage health-care providers to rapidly call the FDA with information about drug side effects. As new drugs are introduced at increasing rates, the FDA will likely need additional resources to protect the public from hazardous drug side effects.
If one or two adverse drug reactions slip through the FDA""s reporting process, the results can be tragic for some patients. That is especially true when the adverse reactions are rare but seriousxe2x80x94such as in the case of liver failure caused by medication. All drugs have the potential to harm or kill the people they are designed to help. An injection of penicillin can kill in minutes if the recipient is allergic to this life-saving drug. Even common aspirin can be deadly.
Clinical trials of a new drug often involve a few hundred patients and therefore may not reveal that a drug can cause serious injury or death in one patient in 10,000 or even 1,000 patients. Accordingly, it is critical for researchers and drug companies to be able to analyze and predict adverse reactions among patients in their studies.
In addition, in clinical trials for drugs used to treat diseases such as diabetes, which affects so many people and is difficult to treat, FDA officials often face tremendous pressure to accelerate their approval process. Often, in this xe2x80x9cfast-trackxe2x80x9d process, cases of adverse drug effects may slip through reporting procedures.
An even bigger challenge to the FDA is the occurrence of adverse drug reactions after the drug is on the market. In this case the drug is prescribed to a much larger population of patients, many of whom are taking other substances such as extracts, nutrients, vitamins, hormones or drugs that might have an adverse effect with the prescribed drug.
Thus, there is a need for effective analysis of adverse drug effects. Unfortunately, such a system has not been available.
U.S. Pat. No. 5,860,917 to Comanor et al., xe2x80x9cMethod And Apparatus For Predicting Therapeutic Outcomesxe2x80x9d discloses methods, software, and systems for evaluating the response of a patient afflicted with a disease to a therapeutic regimen for the disease. In one aspect, the methods, systems, and software are provided for evaluating the utility of a treatment regimen for treating a patient afflicted with a disease. In one embodiment of this aspect, the value of at least one diagnostic variable relating to a statistical model describing the utility of the treatment regimen is determined. The statistical model is derived using a more robust similarity metric least squares (SMILES) analysis of the response to the treatment regimen which has been adapted to include discriminant and logistical analysis. The value of the diagnostic variable is then applied to the model to provide an estimated utility of the treatment regimen in treating the patient. Using the methods, software, and apparatus described therein, robust, statistically significant models of patient responsiveness that reduce the problems associated with present treatment response prediction methods that are brittle and oversimplify the complex interactions among treatment variables can assist patients and clinicians in determining therapies.
U.S. Pat. No. 6,000,828 to Leet, xe2x80x9cMethod Of Improving Drug Treatmentxe2x80x9d discloses a computer implemented method and system for improving drug treatment of patients in local communities by providing drug treatment protocols for particular disease states, such as Diagnosis Related Group (DRG) classifications. The protocol contains ranked recommendations for drug treatments of the disease state, and the computer system collects information about the risks and benefits of the drug treatments. The information collected about the treatments is used to modify the rankings of the drug treatments in the protocol. In one specific embodiment of the system, where the disease state has a microbial etiology and the treatments are anti-microbial drugs, the emergence of drug resistance is quickly detected by determining the percentage of microbial isolates that are found to be resistant to anti-microbial therapy in the community where the therapy is being provided (such as a community hospital or city-wide health care system). An increase in the percentage of resistant isolates produces a re-ranking of recommended drug therapies to avoid further use of the drug to which resistance has developed, and helps quickly introduce more effective drugs that will improve the effectiveness and lower the cost of treatment. In yet other embodiments, a sum of medication (e.g. dosing) errors and adverse effects (e.g. allergic reactions) are tracked by the system to identify drugs that are poorly tolerated in particular populations served by the hospital where the treatment is being provided. Data is collected about the safety and effectiveness of all types of drug therapies in the community being served, and this data is used to modify the drug protocols.
U.S. Pat. No. 6,014,631 to Teagarden et al., xe2x80x9cComputer Implemented Patient Medication Review System And Process For The Managed Care, Health Care And/Or Pharmacy Industryxe2x80x9d discloses an interactive computer assisted method for review and analysis of a patient who needs one or more medications. The method includes the steps of pre-selecting patients to obtain a preliminary set of patients eligible for the interactive computer assisted method responsive to first predetermined criteria, and filtering the preliminary set of patients to identify and form a secondary set of patients from the preliminary set of patients having a greater likelihood of benefiting from the interactive computer assisted method responsive to second predetermined criteria. The method includes the steps of enrolling a patient from the secondary set of patients, and communicating with the patient to obtain information to assist the user in determining whether therapy and/or medication issues are relevant. The method also includes the steps of preliminarily evaluating whether the therapy and medication issues are relevant responsive to the information, and communicating to a physician same. The method also includes the steps of determining whether the therapy and/or medication issues are relevant, and suggesting therapy changes, medication changes, or no changes for the patient.
U.S. Pat. No. 6,082,776 to Feinberg, xe2x80x9cStoring Personal Medical Informationxe2x80x9d discloses a system and method for data compression of structured medical history information using multiple, updatable, static dictionaries in conjunction with an advanced probability-based model. The system is not a free text, word or phrase compressor as is presented in generalized or universal data compression systems. It employs a series of static dictionaries consisting of structured data developed from standardized medical classifications of disease, disorders, surgical procedures and medications. Prior probability information is utilized to achieve a high level of data compression of multiple data items at a time. The dictionaries are designed for flexible updating, efficient storage and retrieval, and data integrity. A portable medical card may be imprinted with the compressed medical information.
U.S. Pat. No. 5,737,539 to Edelson et al., xe2x80x9cPrescription Creation Systemxe2x80x9d discloses an electronic prescription creation system for use by professional prescribers at the point of care which has a prescription division subsystem permitting creation of a single prescription to be automatically divided into two components for fulfillment of one portion quickly and locally at higher cost and of another portion by remote mail order taking more time but providing a cost saving for a major part of the prescription. The prescription creation system has an ability to access remote source databases for system presentation to the prescriber of relevant, authorized and current drug, drug formulary and patient history information, with dynamic creation of a transient virtual patient record, the information being presented to the prescriber before completion of the prescription, permitting enhancement of the quality of prescribing decisions.
U.S. Pat. No. 5,845,255 to Mayaud, xe2x80x9cPrescription Management Systemxe2x80x9d discloses a wirelessly deployable, electronic prescription creation system for physician use which captures into a prescription a patient condition-objective of the prescribed treatment and provides for patient record assembly from source elements, with privacy controls for patient and doctor, adverse indication review and online access to comprehensive drug information including scientific literature.
Extensions to novel multi-drug packages and dispensing devices, and an xe2x80x9cintelligent networkxe2x80x9d remote data retrieval architecture as well as onscreen physician-to-pharmacy and physician-to-physician e-mail are also provided.
U.S. Pat. No. 5,924,074 to Evans, xe2x80x9cElectronic Medical Records Systemxe2x80x9d discloses a medical records system that creates and maintains all patient data electronically. The system captures patient data, such as patient complaints, lab orders, medications, diagnoses, and procedures, at its source at the time of entry using a graphical user interface having touch screens. Using pen-based portable computers with wireless connections to a computer network, authorized healthcare providers can access, analyze, update and electronically annotate patient data even while other providers are using the same patient record. The system likewise permits instant, sophisticated analysis of patient data to identify relationships among the data considered. Moreover, the system includes the capability to access reference databases for consultation regarding allergies, medication interactions and practice guidelines. The system also includes the capability to incorporate legacy data, such as paper files and mainframe data, for a patient.
U.S. Pat. No. 6,219,674 to Classen, xe2x80x9cSystem for creating and managing proprietary product dataxe2x80x9d discloses systems and methods for creating and using product data to enhance the safety of a medical or non-medical product. The systems receive vast amounts of data regarding adverse events associated with a particular product and analyze the data in light of already known adverse events associated with the product. The system develops at least one proprietary database of newly discovered adverse event information and new uses for the product and may catalog adverse event information for a large number of population subgroups. The system may also be programmed to incorporate the information into intellectual property and contract documents. Manufacturers can include the information in consumer product information that they provide to consumers or, in the case of certain medical products, prescribers of the medical products.
However, none of these references provides a web-based system and method for analyzing the risks of adverse effects resulting from the use of a particular drug, either alone or in combination with other substances, including but not limited to hormones, drugs, nutrients, and supplements.
Thus, there remains a need for a more efficient and effective system and method for web-based analysis of the risks of adverse effects resulting from the use of a particular drug, either alone or in combination with other substances including but not limited to hormones, drugs, nutrients, chemicals, toxins, foodstuffs, beverages, and supplements. There also remains a need for a more efficient and effective system and method for web-based analysis of the risks of adverse effects resulting from the use of a particular drug on particular segments of the population.
The system of the present invention is a web-based system for assessing and analyzing the risks of adverse effects resulting from the use of at least one drug of interest, comprising: a selector for identifying at least one drug of interest; a profiler for selecting from multiple profiles related to the safety of the at least one drug of interest, using at least one filter; at least one data mining engine; and an output device for displaying the analytic results from the data mining engine.
The present invention pertains to a computer-implemented method for assessing and analyzing the risks of adverse effects resulting from the use of at least one drug of interest, comprising: storing data regarding the risks of adverse effects from the use of at least one drug of interest in one or more servers linked to the Internet; updating such data regarding the risks with additional information pertinent to the risks of adverse effects from the use of the at least one drug of interest; permitting at least one remote user to access such data through the World Wide Web upon proper authentication; permitting the at least one remote user to identify the at least one drug of interest; permitting the at least one remote user to select data stored in the one or more servers relevant to the safety of using the at least one drug of interest; permitting the at least one remote user to analyze safety issues resulting from use of the at least one drug of interest; and permitting the at least one remote user to display such data and analysis.
The present invention also pertains to a computer-implemented method for assessing and analyzing the risks of adverse effects resulting from the use of at least one substance of interest, comprising: storing data regarding the risks of adverse effects from the use of at least one substance of interest in one or more servers linked to the Internet; updating such data regarding the risks with additional information pertinent to the risks of adverse effects from the use of the at least one Substance of interest; permitting at least one remote user to access such data through the World Wide Web upon proper authentication; permitting the at least one remote user to identify the at least one substance of interest; permitting the at least one remote user to select data stored in the one or more servers relevant to the safety of using the at least one substance of interest; permitting the at least one remote user to analyze safety issues resulting from use of the at least one substance of interest; and permitting the at least one remote user to display such data and analysis.
Preferably, the system and method of the present invention for web-based assessment and analysis of the risks of adverse effects resulting from the use of a drug of interest, either alone or in combination with other drugs, nutrients, supplements, and other substances comprises at least one data mining engine preferably selected from the group consisting of (1) a proportional analysis engine to assess deviations in a set of the reactions to the drug of interest, (2) a comparator to measure the reactions to the drug of interest against a user-defined backdrop, and (3) a correlator to look for correlated signal characteristics in drug/reaction/demographic information; and an output device whereby a user can receive analytic results from the selector, and the at least one data mining engine.
It will appreciated that such a system and method for assessing and analyzing the risks of adverse effects resulting from the use of one or more particular drugs is advantageous to the various risk assessors who are tasked with making such determinations. Such risk assessors include governmental agents who perform such assessment for regulatory purposes, agents of pharmaceutical manufacturers who are tasked with such assessments, health care personnel, such as physicians, nurses, anesthesiologists, as well as patients or anyone prescribed drugs or simply wondering about the safety profile of a particular drug, alone or in combination with other substances.
The Internet is a global network connecting millions of computers. As of 1999, the Internet had more than 200 million users worldwide, and that number is growing rapidly. More than 100 countries are linked into exchanges of data, news and opinions. Unlike online services, which are centrally controlled, the Internet is decentralized by design. Each Internet computer, called a host, is independent. Its operators can choose which Internet services to use and which local services to make available to the global Internet community. There are a variety of ways to access the Internet. Most frequently one gains access to Internet services through a commercial Internet Service Provider (ISP).
The World Wide Web (Web) is a system of Internet servers that support specially formatted documents. The documents are formatted in a language called HTML (HyperText Markup Language) that supports links to other documents, as well as graphics, audio, and video files. This means a user can jump from one document to another simply by clicking on hot spots. There are several applications called Web browsers that make it easy to access the World Wide Web; Two of the most popular being Netscape Navigator and Microsoft""s Internet Explorer.
The Web permits web-based applications. Such web-based applications use TCP/IP and HTTP protocols to transport information from a central network application server to Web clients and back. The interface for the system could be the familiar unmodified Web browser, a Web browser customized with special features, or a unique Web application. These web-enabled applications can be designed to be a single, though massive, application. Navigational features, visual design, and information organization will be uniformly applied. In other web-enabled applications, the components may be designed independently and only linked by a central menued application.
The present invention, which provides a system and method for web-based assessment and analysis of the risks of adverse effects resulting from the use of one or more particular drugs, offers an enhanced degree of analysis not previously available. This enhanced degree of analysis permits the identification of associations and, thus, potential causal elements regarding adverse effects resulting from the use of one or more particular drugs.
The present invention provides answers to several key questions that are essential to public health. For example, various safety groups, both government and private, are charged with monitoring the post-market behavior of drugs and determining xe2x80x9csignalsxe2x80x9d that indicate a relationship among adverse reactions, demographics, and other elements such as outcomes. Unexpected or previously unrecognized adverse drug effects can take the forms of single reactions, groups of reactions, or increases in a labeled reaction. A labeled reaction is a reaction to a drug previously reported to the FDA of such a degree that the FDA-proscribed label for the drug identifies such a reaction to the particular drug. Such adverse drug effects might be due to the higher exposure to the general population experienced in post-market therapy or such effects can be a reaction that has a demographic (genetic or otherwise) emphasis in an age or gender group.
Further, with efficient and effective analysis of adverse drug effects, pharmaceutical research and development professionals can learn more details of the reaction profiles of drugs and the at-risk populations who may be prescribed those drugs. This information would allow a more effective selection of lead compounds and would produce drugs with less risk of adverse effects.
Additionally, the web-based analysis of adverse drug effects of the present invention permits multiple users to concurrently assess the hypotheses regarding the possible existence and causation of the adverse drug effects.
The web-based analysis of adverse drug effects of the present invention also permits users to assess hypotheses regarding the possible existence and causation of the adverse drug effects on a continuous, real-time basis, 24 hours a day, 7 days a week.
The web-based analysis of adverse drug effects of the present invention further permits users to access the application world-wide, without any geographic limitation.
Additionally, the web-based analysis of adverse drug effects of the present invention further permits the application to be run from a server and accessed by standard browsers, thus obviating the need for special software or downloads.
The above-described geographic and coherent/consistent advantages permit greater cooperation among researchers, even if affiliated with different organizations.
Further, the web-based analysis of adverse drug effects of the present invention permits the databases which provide the data regarding adverse drug effects to be updated at regular intervals and to be available for all users at the same time. In addition, such databases (and the application, as well) is maintained in one consistent, coherent format so that all users are employing the same version.
In addition, the web-based analysis of adverse drug effects of the present invention permits alerting of users of emerging issues and standards. Thus, the present invention permits faster response to public health emergencies.
Thus, the present invention provides analysis of adverse drug effects with enhanced speed and flexibility. The present invention also offers new insights with regard to adverse drug effects and augments the existing processes of drug development.
Accordingly, it is an object of the present invention to provide a more efficient and effective system and method for web-based analysis of the risks of adverse effects resulting from the use of a drug, either alone or in combination with other drugs, nutrients, supplements, chemicals, toxins, foodstuffs, beverages and other substances.
It is an object of the present invention to provide a more efficient and effective system and method for web-based analysis of the risks of adverse effects resulting from the use of a drug.
It is further an object of the present invention to provide a more efficient and effective system and method for web-based analysis of the risks of adverse effects resulting from the use of a drug in combination with another substance.
Yet another object of the present invention is to provide a more efficient and effective system and method for web-based analysis of the risks of adverse effects resulting from the use of a drug in combination with another substance, wherein the substance is a nutrient, vitamin, hormone, chemical, toxin, foodstuff, beverage or drug.
An advantage of the present invention is that potential adverse effects to the health of a human or animal may be predicted and avoided.
Yet another object of the present invention is to provide a more efficient and effective system and method useful for web-based analysis of the risks of adverse effects resulting from the use of a drug, alone or in combination with another substance, wherein the substance is a nutrient, vitamin, hormone, or drug, further wherein the system and method can be used by providers of medical or veterinary care services.
Another object of the present invention is to provide a more efficient and effective system and method useful for web-based analysis of the risks of adverse effects resulting from the use of a drug, alone or in combination with another substance, wherein the substance is a nutrient, vitamin, hormone, chemical, toxin, foodstuff, beverage, or drug, further wherein the system and method can be used by consumers of medical care services.
A greater understanding of the present invention and its concomitant advantages will be obtained by referring to the following figure and detailed description provided below.